Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208569
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TERIPARATIDE | TERIPARATIDE | 0.6MG/2.4ML (0.25MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/16/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208569Orig1s000ltr.pdf |
TERIPARATIDE
SOLUTION;SUBCUTANEOUS; 0.6MG/2.4ML (0.25MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FORTEO | TERIPARATIDE | 0.6MG/2.4ML (0.25MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | Yes | AP | 021318 | LILLY |
TERIPARATIDE | TERIPARATIDE | 0.6MG/2.4ML (0.25MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 211097 | APOTEX |
TERIPARATIDE | TERIPARATIDE | 0.6MG/2.4ML (0.25MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | No | AP | 208569 | TEVA PHARMS USA |